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Thermo Scientific Cedia Phencyclidine (pcp) Oft Assay
FDA 510(k)EUDAMEDU (US FDA 510(k))
510(k) K101746
Identifiers
- 510(k) Number
- K101746 FDA 510(k)
- FDA Product Code
- LCM FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Thermo Scientific Cedia Phencyclidine (pcp) Oft Assay by Microgenics Corporation — U — IVDD, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
IVDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K101746 | U | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K101746 24 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 19, 2026